文章摘要
傅行弟.熔融法制备非诺贝特缓释胶囊的处方工艺研究[J].安徽医药,2016,20(5):852-855.
熔融法制备非诺贝特缓释胶囊的处方工艺研究
Formulation and preparation process investigation on fenofibrate sustain-released capsule prepared by melting methodFU Xing-di (Anhui Xianqiu Pharmaceutical Co.Ltd,Langxi,Anhui 242131,China) Abstract:Objective
投稿时间:2016-02-12  
DOI:
中文关键词: 非诺贝特  迟效制剂  工艺学,制药  固体分散体技术
英文关键词: Fenofibrate  Delayed-Action Preparations  Technology,Pharmaceutical  Solid dispersion technique
基金项目:
作者单位
傅行弟 安徽先求药业有限公司,安徽 郎溪 242131 
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中文摘要:
      目的 采用熔融法固体分散体技术代替微丸技术制备非诺贝特缓释胶囊。 方法 将主药与辅料熔融制备缓释颗粒,装入胶囊,以进口品为对照,按国家颁布的质量标准中释放度检查条件考查其释放。 结果 两者体外释放基本一致。 结论 熔融法固体分散体技术制备非诺贝特缓释胶囊较微丸技术简单方便,适合工业生产。
英文摘要:
      Objective Adopt solid dispersion technique with melting method to replace micropellets-capsule method in preparation of fenofibrate sustain-released capsule. Methods Prepare sustain-released granules with active pharmaceutical ingredient(API) and excipients by melting method,and seal above granules in capsules.Using imported drugs as reference,conduct study vitro-release of self-made sustain-released capsule under the drug-release test conditions in quality standards enacted by SFDA. Results The dissolution rate of self-made fenofibrate sustain-released capsule is basically the same as that of imported one. Conclusion The preparation of fenofibrate sustain-released capsule by solid dispersion techniques with melting method is technologically accessible,and could be widely adopted in industrial manufacture.
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